NCT04726683招募中不适用
Trigger Point Dry Needling vs Injection in Patients With Temporomandibular Disorders: a Randomized Placebo-controlled Trial
Josue Fernandez Carnero2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年11月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pain perception (Change is being assessed)
研究概览
简要总结
The main objective is to compare the effectiveness of dry needling in improving pain and disability versus placebo, and versus infiltration, in patients with myofascial temporomandibular dysfunction in the short, medium and long term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 18 and 60 years.
- •Pain of more than 6 weeks of evolution in the craniofacial region.
- •TMD with origin in the masticatory musculature according to the "DC-TMD" criteria.
排除标准
- •Previous injection or dry needling intervention (3 months) on the masseter muscle.
- •Arthrogenous TMD.
- •History of trauma, infection in the temporomandibular joint in the last 6 months.
- •Coagulation disorders.
结局指标
主要结局
Pain perception (Change is being assessed)
时间窗: At baseline, 24h post treatment, at one month, at six months and at twelve months
Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).
次要结局
- Beck Depression Inventory (BDI)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- Believability of placebo(At one week, at two weeks, at three weeks, at for weeks)
- Pain body map(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- Conditioned pain modulation(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- Central sensitization inventory(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- Mandibular Dynamic(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- Disability(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- Temporal summation (TS)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- Fair avoidance beliefs (FAB questionnaire)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- Pressure pain threshold (Change is being assessed)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- Anxiety (STAI questionnaire)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- Expectation of improvement(Baseline, at one week, at two weeks, at three weeks, at for weeks)
- Kinesiophobia (TAMPA scale)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- EQ-5D(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- Pain catastrophizing (PCS)(At baseline, 24h post treatment, at one month, at six months and at twelve months)
- Neuropathic pain(At baseline, 24h post treatment, at one month, at six months and at twelve months)
研究者
Josue Fernandez Carnero
Professor
Universidad Rey Juan Carlos
研究点 (2)
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